The Agreement grants to Emblem the exclusive right in Canada to Canntab’s patents and know-how for the purpose of developing, commercializing, using, selling, and offering the Sustained Release Product for sale under the Emblem brand. The License does not include the right to import or export the Product.
The Sustained Release Product will be manufactured by Emblem or by Canntab, after Canntab receives appropriate licensing allowing such manufacture.
The Agreement calls for Emblem to make payments to Canntab upon achievement of certain milestones involving stability studies, bio-availability studies and regulatory approval of the Sustained Release Product. The Agreement also calls for Emblem to make royalty payments to Canntab based upon Gross Sales of the Product.
Emblem and Canntab also intend to collaborate on the preclinical formulation, clinical development, regulatory approval and commercialization of a range of additional cannabinoid containing pharmaceutical formulations.
There is substantial evidence that cannabinoids are effective for the treatment of a number of conditions including (i) chronic pain (ii) nausea, (iii) anxiety and sleep disorders, and (iv) spasticity in patients with Multiple Sclerosis.
Most conventional (immediate release) dosage forms, such as tablets and capsules, release the active drug component immediately after oral administration. In the formulation of conventional drug products, no deliberate effort is made to modify the drug release rate. Sustained release dosage forms are designed to release the active pharmaceutical ingredient at a predetermined rate in order to maintain a constant drug concentration over a specific period of time – resulting in a longer duration of action from a single dose and often with reduced side effects. Generally this is done to achieve an improved therapeutic outcome and/or to enhance patient compliance. Immediate release dosage forms of cannabinoids tend to lose therapeutic effects in 4 to 6 hours requiring subsequent re-administration and the risk of reduced patient compliance.
The Sustained Release Product is designed to release the cannabinoid content over a period of at least 12 hours. Sustained release formulations of pharmaceutical products are particularly valuable in the treatment of chronic conditions, such as chronic pain, where patients tend to need “around the clock” relief. There is substantial evidence that cannabis is effective for the treatment of numerous conditions including neuropathic pain. Neuropathic pain is estimated to affect over two million Canadians and the pharmaceutical market addressing the needs of those patients was about $500 million in 2016.
John H Stewart – Head of Emblem’s Pharmaceutical Division said: “There are numerous examples of drug products where the utilization of advanced dosage forms such as sustained and/or modified release dosage forms significantly improved the efficacy and clinical utility of the active drug substance. We believe that cannabinoid therapy will be advanced via the development of such dosage forms and the associated pharmacokinetic and clinical research. Sustained release formulations of pharmaceutical ingredients that are otherwise short-acting (such as cannabinoids) have more convenient dosage schedules, a longer duration of action and tend to be much more accepted by patients and healthcare professionals. Emblem expects that the introduction of easily titratable, sustained release formulations of cannabinoids will materially increase the market for cannabinoid-based medications, particularly for treatment of conditions such as chronic neuropathic pain.”